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Tag: FDA

A total of 94 posts are filed under FDA
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FDA Activities for Patient Participation in Medical Product Discussions; Establishment of a Public Docket
The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments on FDA activities performed under the… Continue Reading
Synageva Biopharma Makes New Moves with Sebelipase Alfa for LAL Deficiency
Synageva BioPharma Starts Rolling Submission Of A Biologics License Application To The FDA For Sebelipase Alfa First-Ever Product Submission… Continue Reading
More Patients Help Drug Companies Pass Valley of Death
There’s no question the pharmaceutical industry has boatloads of cash. Global sales of prescription drugs total nearly $1 trillion… Continue Reading
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Navigating the Landscape of Compassionate Use: Siren Interactive Releases New White Paper
A new white paper was released by Siren Interactive on how to help those who may be considering compassionate use. Requests for… Continue Reading
Head of FDA’s Rare Disease Division Departs, Leaving Agency Looking for New Leader
The US Food and Drug Administration (FDA) is looking for a new leader for its Rare Diseases Program. In an email to staff on 16 July 2014,… Continue Reading
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BioCentury Presents: Right To Try Laws
TATES’ RIGHTS BY STEVE USDIN, WASHINGTON EDITOR State right-to-try laws, which have been signed by a Democratic governor in Colorado and a… Continue Reading
Boehringer Ingelheim Announces Nintedanib Expanded Access Program (EAP) for Patients with Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the company has initiated an open-label, U.S. multi-center expanded access… Continue Reading

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